Case 1:19-cv-11586-FDS Document 238-8 Filed 09/14/21 Page 1 of 69
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`Case 1:19-cv-11586-FDS Document 238-8 Filed 09/14/21 Page
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`EXHIBIT H
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`EXHIBIT H
`
`

`

`Case 1:19-cv-11586-FDS Document 238-8 Filed 09/14/21 Page 2 of 69
`Chapter 800 Restriction in Applications Filed Under 35 U.S.C.
`111; Double Patenting
`806.05(g) Apparatus and Product Made — Distinctness
`806.05(h)
`Product and Process of Using
`806.05(i)
`Product, Process of Making, and Process of
`Using — Product Claim Not Allowable
`Patentability Report Practice Has No Effect on
`Restriction Practice
`Reasons for Insisting Upon Restriction
`808
`Independent Inventions
`808.01
`Species
`808.01(a)
`Related Inventions
`808.02
`Claims Linking Distinct Inventions
`809
`Generic Claim Linking Species
`809.02
`809.02(a) Election Required
`809.02(b) Election Required — Generic Claim Allowable
`809.02(c) Action Following Election
`809.02(d) No Species Claims
`809.02(e) Generic Claim Allowable in Substance
`809.03
`Linking Claims
`809.04
`Retention of Claims to Nonelected Invention
`810
`Action on the Merits
`810.01
`Not Objectionable When Coupled With
`Requirement
`Usually Deferred
`Given on Elected Invention When Require-
`ment Is Made Final
`Time for Making Requirement
`Even After Compliance With Preceding
`Requirement
`Repeating After Withdrawal Proper
`Proper Even Though Grouped Together in
`Parent Application
`Who Should Make the Requirement
`Telephone Restriction Practice
`Indicate Exactly How Application Is To
`Be Restricted
`Make Requirement Complete
`Give Reasons for Holding of Independence
`or Distinctness
`Outline of Letter for Restriction Requirement
`Between Distinct Inventions
`Election and Reply
`818
`Election Fixed by Action on Claims
`818.01
`Election Other Than Express
`818.02
`818.02(a) By Originally Presented Claims
`818.02(b) Generic Claims Only — No Election
`of Species
`818.02(c) By Optional Cancellation of Claims
`818.03
`Express Election and Traverse
`818.03(a) Reply Must Be Complete
`818.03(b) Must Elect, Even When Requirement
`Is Traversed
`818.03(c) Must Traverse To Preserve Right of Petition
`
`801
`802
`802.01
`802.02
`803
`803.01
`
`803.04
`804
`804.01
`
`804.02
`804.03
`
`804.04
`805
`806
`
`806.01
`806.02
`
`806.03
`
`Introduction
`Basis for Practice in Statute and Rules
`Meaning of “Independent” and “Distinct”
`Definition of Restriction
`Restriction - When Proper
`Review by Examiner With at Least Partial
`Signatory Authority
`Restriction — Markush Claims
`803.02
`Restriction — Transitional Applications
`803.03
`803.03(a) Transitional Application — Linking Claim
`Allowable
`803.03(b) Transitional Application — Generic Claim
`Allowable
`Restriction - Nucleotide Sequences
`Definition of Double Patenting
`Prohibition of Double Patenting Rejections
`Under 35 U.S.C. 121
`Avoiding a Double Patenting Rejection
`Treatment of Commonly Owned Cases of
`Different Inventive Entities
`Submission to Technology Center Director
`Effect of Improper Joinder in Patent
`Determination of Distinctness or Independence
`of Claimed Inventions
`Compare Claimed Subject Matter
`Patentability Over the Prior Art Not Consid-
`ered
`Single Embodiment, Claims Defining Same
`Essential Features
`Independent Inventions
`806.04
`Species — Genus
`806.04(a)
`Species May Be Related Inventions
`806.04(b)
`Subcombination Not Generic to Combination
`806.04(c)
`806.04(d) Definition of a Generic Claim
`806.04(e) Claims Restricted to Species
`806.04(f) Claims Restricted to Species, by Mutually
`Exclusive Characteristics
`Species Must Be Patentably Distinct From
`Each Other
`806.04(i) Generic Claims Presented for First Time After
`Issue of Species
`Related Inventions
`806.05
`806.05(a) Combination and Subcombination or Element
`806.05(b) Old Combination — Novel Subcombination
`806.05(c) Criteria of Distinctness for Combination,
`Subcombination, or Element of a Combination
`Subcombinations Usable Together
`Process and Apparatus for Its Practice —
`Distinctness
`Process of Making and Product Made —
`Distinctness
`
`Restriction in Applications Filed Under 35 U.S.C. 111; Double Patenting
`
`807
`
`810.02
`810.03
`
`811
`811.02
`
`811.03
`811.04
`
`812
`812.01
`814
`
`815
`816
`
`817
`
`800-1
`
`August 2001
`
`806.04(h)
`
`806.05(d)
`806.05(e)
`
`806.05(f)
`
`

`

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`801
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`818.03(d) Traverse of Nonallowance of Linking Claims
`818.03(e) Applicant Must Make Own Election
`819
`Office Generally Does Not Permit Shift
`819.01
`Office May Waive Election and Permit Shift
`820
`Not an Election; Permissible Shift
`820.01
`Old Combination Claimed — Not an Election
`820.02
`Interference Issues — Not an Election
`821
`Treatment of Claims Held To Be Drawn to
`Nonelected Inventions
`After Election With Traverse
`After Election Without Traverse
`Claims for Different Invention Added After
`an Office Action
`Rejoinder
`Claims to Inventions That Are Not Distinct in
`Plural Applications of Same Inventive Entity
`Copending Before the Examiner
`Unity of Invention Under the Patent
`Cooperation Treaty
`
`821.01
`821.02
`821.03
`
`821.04
`822
`
`822.01
`823
`
`801
`
`Introduction
`
`This chapter is limited to a discussion of the subject
`of restriction and double patenting under Title 35 of
`the United States Code and Title 37 of the Code of
`Federal Regulations as it relates to national applica-
`tions filed under 35 U.S.C. 111(a). The discussion of
`unity of invention under the Patent Cooperation
`Treaty Articles and Rules as it is applied as an Inter-
`national Searching Authority, International Prelimi-
`nary Examining Authority, and
`in applications
`entering the National Stage under 35 U.S.C. 371 as a
`Designated or Elected Office in the U.S. Patent and
`Trademark Office is covered in Chapter 1800.
`
`802
`
`Basis for Practice in Statute
`and Rules
`
`The basis for restriction and double patenting prac-
`tices is found in the following statute and rules:
`
`35 U.S.C. 121. Divisional applications.
`If two or more independent and distinct inventions are claimed
`in one application, the Director may require the application to be
`restricted to one of the inventions. If the other invention is made
`the subject of a divisional application which complies with the
`requirements of section 120 of this title it shall be entitled to the
`benefit of the filing date of the original application. A patent issu-
`ing on an application with respect to which a requirement for
`restriction under this section has been made, or on an application
`filed as a result of such a requirement, shall not be used as a refer-
`
`ence either in the Patent and Trademark Office or in the courts
`against a divisional application or against the original application
`or any patent issued on either of them, if the divisional application
`is filed before the issuance of the patent on the other application.
`If a divisional application is directed solely to subject matter
`described and claimed in the original application as filed, the
`Director may dispense with signing and execution by the inventor.
`The validity of a patent shall not be questioned for failure of the
`Director to require the application to be restricted to one inven-
`tion.
`
`37 CFR 1.141. Different inventions in one national
`application.
`(a) Two or more independent and distinct inventions may not
`be claimed in one national application, except that more than one
`species of an invention, not to exceed a reasonable number, may
`be specifically claimed in different claims in one national applica-
`tion, provided the application also includes an allowable claim
`generic to all the claimed species and all the claims to species in
`excess of one are written in dependent form (§ 1.75) or otherwise
`include all the limitations of the generic claim.
`(b) Where claims to all three categories, product, process of
`making, and process of use, are included in a national application,
`a three way requirement for restriction can only be made where
`the process of making is distinct from the product. If the process
`of making and the product are not distinct, the process of using
`may be joined with the claims directed to the product and the pro-
`cess of making the product even though a showing of distinctness
`between the product and process of using the product can be
`made.
`
`37 CFR 1.142. Requirement for restriction.
`(a) If two or more independent and distinct inventions are
`claimed in a single application, the examiner in an Office action
`will require the applicant in the reply to that action to elect an
`invention to which the claims will be restricted, this official action
`being called a requirement for restriction (also known as a
`requirement for division). Such requirement will normally be
`made before any action on the merits; however, it may be made at
`any time before final action.
`(b) Claims to the invention or inventions not elected, if not
`canceled, are nevertheless withdrawn from further consideration
`by the examiner by the election, subject however to reinstatement
`in the event the requirement for restriction is withdrawn or over-
`ruled.
`
`The pertinent Patent Cooperation Treaty (PCT)
`Articles and Rules are cited and discussed in Chapter
`1800. Sections 1850, 1875, and 1893.03(d) should be
`consulted for discussions on unity of invention:
`
`(A) before the International Searching Authority;
`(B) before the International Preliminary Examin-
`ing Authority; and
`(C) in the National Stage under 35 U.S.C. 371.
`
`August 2001
`
`800-2
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`

`

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`RESTRICTION IN APPLICATION FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803
`
`802.01 Meaning of “Independent”
`and “Distinct”
`
`35 U.S.C. 121 quoted in the preceding section
`states that the Commissioner may require restriction if
`two or more “independent and distinct” inventions are
`claimed in one application. In 37 CFR 1.141, the
`statement is made that two or more “independent and
`distinct inventions” may not be claimed in one appli-
`cation.
`This raises the question of the subjects as between
`which the Commissioner may require restriction.
`This, in turn, depends on the construction of the
`expression “independent and distinct” inventions.
`“Independent”, of course, means not dependent. If
`“distinct” means the same thing, then its use in the
`statute and in the rule is redundant. If “distinct” means
`something different, then the question arises as to
`what the difference in meaning between these two
`words may be. The hearings before the committees of
`Congress considering the codification of the patent
`laws indicate that 35 U.S.C. 121: “enacts as law exist-
`ing practice with respect to division, at the same time
`introducing a number of changes.”
`The report on the hearings does not mention as a
`change that is introduced, the subjects between which
`the Commissioner may properly require division.
`The term “independent” as already pointed out,
`means not dependent. A large number of subjects
`between which, prior to the 1952 Act, division had
`been proper, are dependent subjects, such as, for
`example, combination and a subcombination thereof;
`as process and apparatus used in the practice of the
`process; as composition and the process in which the
`composition is used; as process and the product made
`by such process, etc. If section 121 of the 1952 Act
`were intended to direct the Commissioner never to
`approve division between dependent inventions, the
`word “independent” would clearly have been used
`alone. If the Commissioner has authority or discretion
`to restrict independent inventions only, then restric-
`tion would be improper as between dependent inven-
`tions, e.g.,
`the examples used for purpose of
`illustration above. Such was clearly not the intent of
`Congress. Nothing in the language of the statute and
`nothing in the hearings of the committees indicate any
`intent to change the substantive law on this subject.
`On the contrary, joinder of the term “distinct” with the
`
`term “independent”, indicates lack of such intent. The
`law has long been established that dependent inven-
`tions (frequently termed related inventions) such as
`used for illustration above may be properly divided if
`they are, in fact,“distinct” inventions, even though
`dependent.
`
`INDEPENDENT
`
`The term “independent” (i.e., not dependent) means
`that there is no disclosed relationship between the two
`or more subjects disclosed, that is, they are uncon-
`nected in design, operation, or effect, for example: (1)
`species under a genus which species are not usable
`together as disclosed; or (2) process and apparatus
`incapable of being used in practicing the process.
`
`DISTINCT
`
`The term “distinct” means that two or more sub-
`jects as disclosed are related, for example, as combi-
`nation and part (subcombination) thereof, process and
`apparatus for its practice, process and product made,
`etc., but are capable of separate manufacture, use, or
`sale as claimed, AND ARE PATENTABLE (novel
`and unobvious) OVER EACH OTHER (though they
`may each be unpatentable because of the prior art). It
`will be noted that in this definition the term related is
`used as an alternative for dependent in referring to
`subjects other than independent subjects.
`It is further noted that the terms “independent” and
`“distinct” are used in decisions with varying mean-
`ings. All decisions should be read carefully to deter-
`mine the meaning intended.
`
`802.02
`
`Definition of Restriction
`
`Restriction, a generic term, includes the practice of
`requiring an election between distinct inventions, for
`example, election between combination and subcom-
`bination inventions, and the practice relating to an
`election between independent inventions, for exam-
`ple, and election of species.
`
`803
`
`Restriction - When Proper
`
`Under the statute an application may properly be
`required to be restricted to one of two or more
`claimed inventions only if they are able to support
`separate patents and they are either independent
`
`800-3
`
`August 2001
`
`

`

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`
`803.01
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`(MPEP § 806.04 - § 806.04(i)) or distinct (MPEP
`§ 806.05 - § 806.05(i)).
`If the search and examination of an entire applica-
`tion can be made without serious burden, the exam-
`iner must examine it on the merits, even though it
`includes claims to independent or distinct inventions.
`
`CRITERIA FOR RESTRICTION BETWEEN
`PATENTABLY DISTINCT INVENTIONS
`
`There are two criteria for a proper requirement for
`restriction between patentably distinct inventions:
`
`(A) The inventions must be independent (see
`MPEP § 802.01, § 806.04, § 808.01) or distinct as
`claimed (see MPEP § 806.05 - § 806.05(i)); and
`(B) There must be a serious burden on the exam-
`iner if restriction is required (see MPEP § 803.02,
`§ 806.04(a) - § 806.04(i), § 808.01(a), and § 808.02).
`
`GUIDELINES
`
`Examiners must provide reasons and/or examples
`to support conclusions, but need not cite documents to
`support the restriction requirement in most cases.
`Where plural inventions are capable of being
`viewed as related in two ways, both applicable criteria
`for distinctness must be demonstrated to support a
`restriction requirement.
`If there is an express admission that the claimed
`inventions are obvious over each other within the
`meaning of 35 U.S.C. 103, restriction should not be
`required. In re Lee, 199 USPQ 108 (Comm’r Pat.
`1978).
`For purposes of the initial requirement, a serious
`burden on the examiner may be prima facie shown if
`the examiner shows by appropriate explanation of
`separate classification, or separate status in the art, or
`a different field of search as defined in MPEP
`§ 808.02. That prima facie showing may be rebutted
`by appropriate showings or evidence by the applicant.
`Insofar as the criteria for restriction practice relating
`to Markush-type claims is concerned, the criteria is
`set forth in MPEP § 803.02. Insofar as the criteria for
`restriction or election practice relating to claims to
`genus-species, see MPEP § 806.04(a) - § 806.04(i)
`and § 808.01(a).
`
`803.01
`
`Review by Examiner with
`at Least Partial Signatory
`Authority
`
`Since requirements for restriction under 35 U.S.C.
`121 are discretionary with the Commissioner, it
`becomes very important that the practice under this
`section be carefully administered. Notwithstanding
`the fact that this section of the statute apparently pro-
`tects the applicant against the dangers that previously
`might have resulted from compliance with an
`improper requirement for restriction, IT STILL
`REMAINS IMPORTANT FROM THE STAND-
`POINT OF THE PUBLIC INTEREST THAT NO
`REQUIREMENTS BE MADE WHICH MIGHT
`RESULT IN THE ISSUANCE OF TWO PATENTS
`FOR THE SAME INVENTION. Therefore, to guard
`against this possibility, only an examiner with perma-
`nent or temporary full signatory authority may sign
`final and non-final Office actions containing a final
`requirement for restriction, except that an examiner
`with permanent or temporary partial signatory author-
`ity may sign non-final Office actions containing a
`final requirement for restriction.
`
`803.02
`
`Restriction — Markush Claims
`
`PRACTICE RE MARKUSH-TYPE CLAIMS
`
`If the members of the Markush group are suffi-
`ciently few in number or so closely related that a
`search and examination of the entire claim can be
`made without serious burden, the examiner must
`examine all the members of the Markush group in the
`claim on the merits, even though they are directed to
`independent and distinct inventions. In such a case,
`the examiner will not follow the procedure described
`below and will not require restriction.
`Since the decisions in In re Weber, 580 F.2d 455,
`198 USPQ 328 (CCPA 1978) and In re Haas, 580
`F.2d 461, 198 USPQ 334 (CCPA 1978), it is improper
`for the Office to refuse to examine that which appli-
`cants regard as their invention, unless the subject mat-
`ter in a claim lacks unity of invention. In re Harnish,
`631 F.2d 716, 206 USPQ 300 (CCPA 1980); and Ex
`parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int.
`1984). Broadly, unity of invention exists where com-
`pounds included within a Markush group (1) share a
`
`August 2001
`
`800-4
`
`

`

`Case 1:19-cv-11586-FDS Document 238-8 Filed 09/14/21 Page 6 of 69
`
`RESTRICTION IN APPLICATION FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803.03
`
`common utility, and (2) share a substantial structural
`feature disclosed as being essential to that utility.
`This subsection deals with Markush-type generic
`claims which include a plurality of alternatively
`usable substances or members. In most cases, a recita-
`tion by enumeration is used because there is no appro-
`priate or true generic language. A Markush-type claim
`can include independent and distinct inventions. This
`is true where two or more of the members are so unre-
`lated and diverse that a prior art reference anticipating
`the claim with respect to one of the members would
`not render the claim obvious under 35 U.S.C. 103
`with respect to the other member(s). In applications
`containing claims of that nature, the examiner may
`require a provisional election of a single species prior
`to examination on the merits. The provisional election
`will be given effect in the event that the Markush-type
`claim should be found not allowable. Following elec-
`tion, the Markush-type claim will be examined fully
`with respect to the elected species and further to the
`extent necessary to determine patentability. If the
`Markush-type claim is not allowable over the prior
`art, examination will be limited to the Markush-type
`claim and claims to the elected species, with claims
`drawn to species patentably distinct from the elected
`species held withdrawn from further consideration.
`As an example, in the case of an application with a
`Markush-type claim drawn to the compound C-R,
`wherein R is a radical selected from the group consist-
`ing of A, B, C, D, and E, the examiner may require a
`provisional election of a single species, CA, CB, CC,
`CD, or CE. The Markush-type claim would then be
`examined fully with respect to the elected species and
`any species considered to be clearly unpatentable over
`the elected species. If on examination the elected spe-
`cies is found to be anticipated or rendered obvious by
`prior art, the Markush-type claim and claims to the
`elected species shall be rejected, and claims to the
`nonelected species would be held withdrawn from
`further consideration. As in the prevailing practice, a
`second action on the rejected claims would be made
`final.
`On the other hand, should no prior art be found that
`anticipates or renders obvious the elected species, the
`search of the Markush-type claim will be extended. If
`prior art is then found that anticipates or renders obvi-
`ous the Markush-type claim with respect to a non-
`elected species, the Markush-type claim shall be
`
`rejectedand claims to the nonelected species held
`withdrawn from further consideration. The prior art
`search, however, will not be extended unnecessarily
`to cover all nonelected species. Should applicant, in
`response to this rejection of the Markush-type claim,
`overcome the rejection, as by amending the Markush-
`type claim to exclude the species anticipated or ren-
`dered obvious by the prior art, the amended Markush-
`type claim will be reexamined. The prior art search
`will be extended to the extent necessary to determine
`patentability of the Markush-type claim. In the event
`prior art is found during the reexamination that antici-
`pates or renders obvious the amended Markush-type
`claim, the claim will be rejected and the action made
`final. Amendments submitted after the final rejection
`further restricting the scope of the claim may be
`denied entry.
`
`803.03
`
`Restriction — Transitional
`Applications
`
`PRACTICE RE TRANSITIONAL APPLICA-
`TION
`
`37 CFR 1.129. Transitional procedures for limited
`examination after final rejection and restriction practice.
`
`*****
`
`(b)(1) In an application, other than for reissue or a design
`patent, that has been pending for at least three years as of June 8,
`1995, taking into account any reference made in the application to
`any earlier filed application under 35 U.S.C. 120, 121 and 365(c),
`no requirement for restriction or for the filing of divisional appli-
`cations shall be made or maintained in the application after June
`8, 1995, except where:
`(i) The requirement was first made in the application or
`any earlier filed application under 35 U.S.C. 120, 121 and 365(c)
`prior to April 8, 1995;
`(ii) The examiner has not made a requirement for
`restriction in the present or parent application prior to April 8,
`1995, due to actions by the applicant; or
`(iii) The required fee for examination of each addi-
`tional invention was not paid.
`(2) If the application contains more than one independent
`and distinct invention and a requirement for restriction or for the
`filing of divisional applications cannot be made or maintained
`pursuant to this paragraph, applicant will be so notified and given
`a time period to:
`(i) Elect the invention or inventions to be searched
`and examined, if no election has been made prior to the notice,
`and pay the fee set forth in 1.17(s) for each independent and dis-
`tinct invention claimed in the application in excess of one which
`applicant elects;
`
`800-5
`
`August 2001
`
`

`

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`803.03
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`(ii) Confirm an election made prior to the notice and
`pay the fee set forth in § 1.17(s) for each independent and distinct
`invention claimed in the application in addition to the one inven-
`tion which applicant previously elected; or
`(iii) File a petition under this section traversing the
`requirement. If the required petition is filed in a timely manner,
`the original time period for electing and paying the fee set forth in
`§ 1.17(s) will be deferred and any decision on the petition affirm-
`ing or modifying the requirement will set a new time period to
`elect the invention or inventions to be searched and examined and
`to pay the fee set forth in § 1.17(s) for each independent and dis-
`tinct invention claimed in the application in excess of one which
`applicant elects.
`(3) The additional inventions for which the required fee
`has not been paid will be withdrawn from consideration under
`§ 1.142(b). An applicant who desires examination of an invention
`so withdrawn from consideration can file a divisional application
`under 35 U.S.C. 121.
`(c) The provisions of this section shall not be applicable to
`any application filed after June 8, 1995.
`
`“Restriction” under 37 CFR 1.129(b) applies to
`both restriction requirements under 37 CFR 1.142 and
`election of species requirements under 37 CFR 1.146.
`37 CFR 1.129(b)(1) provides for examination of
`more than one independent and distinct invention in
`certain applications pending for 3 years or longer as
`of June 8, 1995, taking into account any reference to
`any earlier application under 35 U.S.C. 120, 121, or
`365(c). Applicant will not be permitted to have such
`additional invention(s) examined in an application if:
`
`(A) the requirement was made in the application
`or in an earlier application relied on under 35 U.S.C.
`120, 121, or 365(c) prior to April 8, 1995;
`(B) no restriction requirement was made with
`respect to the invention(s) in the application or earlier
`application prior to April 8, 1995, due to actions by
`the applicant; or
`(C) the required fee for examination of each addi-
`tional invention was not paid.
`
`Only if one of these exceptions applies is a normal
`restriction requirement appropriate and telephone
`restriction practice may be used.
`Examples of what constitute “actions by the appli-
`cant” in 37 CFR 1.129(b)(1) are:
`
`(A) applicant abandoned the application and con-
`tinued to refile the application such that no Office
`action could be issued in the application,
`
`(B) applicant requested suspension of prosecution
`under 37 CFR 1.103(a) such that no Office action
`could be issued in the application,
`
`(C) applicant disclosed a plurality of independent
`and distinct inventions in the present or parent appli-
`cation, but delayed presenting claims to more than
`one of the disclosed independent and distinct inven-
`tions in the present or parent application such that no
`restriction requirement could be made prior to April 8,
`1995, and
`
`(D) applicant combined several applications, each
`of which claimed a different independent and distinct
`invention, into one large “continuing” application, but
`delayed filing the continuing application first claim-
`ing more than one independent and distinct invention
`such that no restriction requirement could be made
`prior to April 8, 1995.
`
`In examples (A) and (B), the fact that the present or
`parent application claiming independent and distinct
`inventions was on an examiner’s docket for at least 3
`months prior to abandonment or suspension, or in
`examples (C) and (D), the fact that the amendment
`claiming independent and distinct inventions was first
`filed, or the continuing application first claiming the
`additional independent and distinct inventions was on
`an examiner’s docket, at least 3 months prior to April
`8, 1995, is prima facie evidence that applicant’s
`actions did not prevent the Office from making a
`requirement for restriction with respect to those inde-
`pendent and distinct inventions prior to April 8, 1995.
`Furthermore, an extension of time under 37 CFR
`1.136(a) does not constitute such “actions by the
`applicant” under 37 CFR 1.129(b)(1).
`NOTE: If an examiner believes an application falls
`under the exception that no restriction could be made
`prior to April 8, 1995, due to applicant's action, the
`application must be brought to the attention of the
`Technology Center (TC) Special Program Examiner
`for review.
`
`Under 37 CFR 1.129(b)(2), if the application con-
`tains claims to more than one independent and distinct
`invention, and no requirement for restriction or for the
`filing of divisional applications can be made or main-
`tained, applicant will be notified and given a time
`period to:
`
`August 2001
`
`800-6
`
`

`

`Case 1:19-cv-11586-FDS Document 238-8 Filed 09/14/21 Page 8 of 69
`
`RESTRICTION IN APPLICATION FILED UNDER 35 U.S.C. 111; DOUBLE PATENTING
`
`803.03(b)
`
`(A) elect the invention or inventions to be
`searched and examined, if no election has been made
`prior to the notice, and pay the fee set forth in 37 CFR
`1.17(s) for each independent and distinct invention
`claimed in the application in excess of one which
`applicant elects,
`(B) in situations where an election was made in
`reply to a requirement for restriction that cannot be
`maintained, confirm the election made prior to the
`notice and pay the fee set forth in 37 CFR 1.17(s) for
`each independent and distinct invention claimed in
`the application in addition to the one invention which
`applicant previously elected, or
`(C) file a petition under 37 CFR 1.129(b)(2) tra-
`versing the requirement without regard to whether the
`requirement has been made final. No petition fee is
`required.
`
`37 CFR 1.129(b)(2) also provides that if the peti-
`tion is filed in a timely manner, the original time
`period for electing and paying the fee set forth in
`37 CFR 1.17(s) will be deferred and any decision on
`the petition affirming or modifying the requirement
`will set a new time period to elect the invention or
`inventions to be searched and examined and to pay
`the fee set forth in 37 CFR 1.17(s) for each indepen-
`dent and distinct invention claimed in the application
`in excess of one which applicant elects.
`Under 37 CFR 1.129(b)(3), each additional inven-
`tion for which the required fee set forth in 37 CFR
`1.17(s) has not been paid will be withdrawn from con-
`sideration under 37 CFR 1.142(b). An applicant who
`desires examination of an invention so withdrawn
`from consideration can file a divisional application
`under 35 U.S.C. 121.
`37 CFR 1.129(c) clarifies that the provisions of
`37 CFR 1.129(a) and (b) are not applicable to any
`application filed after June 8, 1995. However, any
`application filed on June 8, 1995, would be subject to
`a 20-year patent term.
`Form paragraph 8.41 may be used to notify appli-
`cant that the application is a transitional application
`and is entitled to consideration of additional inven-
`tions upon payment of the required fee.
`
`¶ 8.41 Transitional Restriction or Election of Species
`Requirement To Be Mailed After June 8, 1995
`This application is subject to the transitional restriction provi-
`sions of Public Law 103-465, which became effective on June 8,
`1995, because:
`
`the application was filed on or before June 8, 1995, and
`1.
`has an effective U.S. filing date of June 8, 1992, or earlier;
`2.
`a requirement for restriction was not made in the present
`or a parent application prior to April 8, 1995; and
`3.
`the examiner was not prevented from making a require-
`ment for restriction in the present or a parent application prior to
`April 8, 1995, due to actions by the applicant.
`
`The transitional restriction provisions permit applicant to have
`more than one independent and distinct invention examined in the
`same application by paying a fee for each invention in excess of
`one.
`Final rules concerning the transition restriction provisions were
`published in the Federal Register at 60 FR 20195 (April 25, 1995)
`and in the Official Gazette at 1174 O.G. 15 (May 2, 1995). The
`final rules at 37 CFR 1.17(s) include the fee amount required to be
`paid for each additional invention as set forth in the following
`requirement for restriction. See the current fee schedule for the
`proper amount of the fee.
`Applicant must either: (1) elect the invention or inventions to
`be searched and examined and pay the fee set forth in 37 CFR
`1.17(s) for each independent and distinct invention in excess of
`one which applicant elects; or (2) file a petition under 37 CFR
`1.129(b) traversing the requirement.
`
`Examiner Note:
`1.
`This form paragraph should be used in all restriction or elec-
`tion of species requirements made in applications subject to the
`transition restriction provisions set forth in 37 CFR 1.129(b)
`where the requirement is being mailed after June 8, 1995. The
`procedure is NOT applicable to any design or reissue application.
`
`803.03(a) Transitional Application —
`Linking Claim Allowable
`
`Whenever divided inventions in a transitional
`application are rejoined because a linking claim is
`allowed (MPEP § 809) and applicant paid the fee set
`forth in 37 CFR 1.17(s) for the additional invention,
`applicant should be notified that he or she may
`request a refund of the fee paid for that additional
`invention.
`
`803.03(b) Transitional Application —
`Generic Claim Allowable
`
`Whenever claims drawn to an additional species in
`a transitional application for which applicant paid the
`fee set forth in 37 CFR 1.17(s) are no longer with-
`drawn from consideration because they are fully
`embraced by an allowed generic claim, applicant
`should be notified that he or she may request